The Effects of Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients

Official title

The Effects of Acute and Chronic Exercise on the Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients

Overview

This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.

Detailed description

PRIMARY OBJECTIVES:

I. Determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of CLL patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.

II. Determine how circulating immune cell mobilization and function (cell counts \& cytokine profile) of CLL patients respond to a 12-week semi-supervised training program of moderate to high intensity, aerobic based exercise.

III. Evaluate the effectiveness of 12-weeks of semi-supervised exercise training (ET) versus (vs.) usual care (UC) at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent non-Hodgkin (NHL) lymphoma during or after treatment.

IV. Determine that extent to which 12-weeks of semi-supervised ET can modify circulating immune cell mobilization and immune function in individuals with indolent NHL during or after treatment compared to UC.

V. Development of a forward-chaining AI expert system using both manual and physiology derived feedback to optimize training results and compare its efficacy at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent NHL and CLL to that of the semi-supervised ET.

OUTLINE: CLL patients and healthy participants are assigned to Aim 1. CLL patients who complete all Aim 1 activities are assigned to Aim 2. Patients with indolent NHL will be assigned to Aims 3 and 4.

AIM 1: Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (cardiopulmonary exercise testing \[CPET\]), and undergo collection of blood samples on study. Participants may also undergo dual X-ray absorptiometry (DEXA) scan on study.

AIM 2: CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.

AIMS 3-4: Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6-minute walk test (6MWT). Patients are then randomized to 1 of 2 arms.

ARM I: Patients receive usual care on study.

ARM II: Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.

AIM 5: All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.

After completion of study intervention, patients are followed up every 6 months (Aims 2-4) or annually (Aim 5) for 3 years.

Interventions

• Procedure Biospecimen Collection
  Undergo collection of blood
• Other Cardiopulmonary Exercise Testing
  Undergo CPET
• Procedure Dual X-ray Absorptiometry
  Undergo DEXA scan
• Other Electronic Health Record Review
  Ancillary studies
• Other Exercise Intervention
  Undergo aerobic based training program
• Procedure Physical Examination
  Undergo measurement of height/weight and vital signs
• Other Questionnaire Administration
  Ancillary studies
• Procedure Spirometry
  Undergo spirometry
• Other Physical Performance Testing
  Undergo muscular strength and functional endurance measurements
• Other Best Practice
  Receive usual care

Primary outcome measures

• Assess circulating immune cell abundance and function pre-intervention [Time frame: Baseline]
• Assess circulating immune cell mobilization and function post-intervention [Time frame: Up to 12 weeks]

Eligibility criteria

Inclusion criteria

• English speaking
• Between the ages of 18-80
• Histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study

Exclusion criteria

• Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g. heart disease, coronary artery disease, chronic obstructive pulmonary disease \[COPD\], asthma, etc.) an orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker
• Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those who have already received treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals that are participating prior to receiving treatment must not have any scheduled treatments during their participation. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT05876923 · 22-012246 · NCI-2023-03210 · 22-012246

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗